RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move
across top level links and expand / close menus in sub levels. Up and Down arrows will open main level
menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab
will move on to the next part of the site rather than go through menu items.

About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

As White House Announces Breakthrough for FDA in China, Could Warning Letters Increase?

If you follow the US Food and Drug Administration's (FDA) Warning Letters with any regularity, you know that the agency has been keeping a tight eye on Indian pharmaceutical manufacturers. But under the terms of a recent agreement, Chinese companies might soon find themselves in similar circumstances.

Background

FDA has long been hamstrung in its ability to inspect foreign manufacturers of pharmaceutical products, and in particular generic pharmaceuticals and active pharmaceutical ingredients (APIs) used in both. That's because foreign inspections are considerably more difficult and expensive to conduct. It costs more to travel there, inspectors need to obtain temporary or permanent visas, translators need to be made available, and sometimes just accessing a facility can be a burden.

But that situation underwent several major changes in 2012 under the terms of the Food and Drug Administration Safety and Innovation Act (FDASIA).

FDASIA contained two major provisions that are proving instrumental in increasing foreign-based inspections. First, it contains the Generic Drug User Fee Act (GDUFA), which for the first time ever allows FDA to collect user fees from all manufacturers and sponsors of generic drugs and APIs to help fund the inspection of those facilities.

Boots on the Ground in India, Eyes on China

Those authorities have had a lot to do with a surge in inspections this year in India, where FDA has sent several major Warning Letters to large manufacturers alleging serious problems. As Focus noted last week, recipients include Wockhardt (2), Fresenius, Hospira, Promed and Posh Chemicals.

But why the focus on India? After all, prior to the passage of FDASIA, FDA investigators had found plenty of objectionable conditions in Chinese facilities. If Warning Letters have a conspicuous absence of anything this year, it's objectionable conditions found in Chinese facilities.

In 2013, FDA has issued just five Warning Letters to companies based in China. By contrast, Chinese companies received 15 the year before.

As Ed Silverman of Pharmalot has reported, the perceived focus on India might not be an accident. In August 2013, Silverman reported that FDA had been unable to obtain visas for its staffers to work on a long-term basis in the country, something made possible by $10 million in FDA funding through FDASIA.

Permanent FDA outposts are intended to make routine inspections easier, but without being able to send new staff to its China facility, FDA's inspection capabilities have been stagnant.

"[So] far, the agency has been unable to send more investigators, except those who are permitted to make short-term trips to conduct inspections," Silverman wrote.

The Situation in China: Due to Change?

But now that situation is poised to change, an FDA representative tells Focus. Under the terms of an agreement reached on 5 December 2013 between the White House and Chinese officials, China will allow a "substantial increase in the number of US food and drug inspectors stationed in China," according to a White House statement.

"China also committed to take steps towards introducing a framework for registering manufacturers of bulk chemicals that can be used as active pharmaceutical ingredients, which would be a critical step in combatting dangerous counterfeit pharmaceuticals around the world," the White House statement continues. "In addition, China took an important step to strengthen the protection of pharmaceutical innovations by announcing that patent holders will be able to submit additional data to support their patents after filing their initial applications."

While the move is undoubtedly positive for the US pharmaceutical industry at large owing to its increased patent protections, it also raises the prospect of something else: More Warning Letters for Chinese manufacturers.

India, which saw just six Warning Letters in 2012, has already seen 13 Warning Letters since FDAISA became law.

If similar trends hold true for Chinese companies, 2014 could be as excruciating for them as 2013 was for Indian manufacturers.